Evidence map›Paper›PMID 41920295›Full record

ArticleInfectious diseases and therapy2026

Prospective Study of Treatment with Ensitrelvir for COVID-19 in Patients Undergoing Hemodialysis (PROTECT-HD).

Mineaki Kitamura, Takahiro Takazono, Naoki Hosogaya, Shimpei Morimoto, Masahiro Kinoshita, Eriko Hamada, Ryosuke Shimizu, Shogo Miyazawa, Shintaro Tanaka, Tomoya Nishino and 1 more

Abstract read
In one paragraph

Article in Infectious diseases and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Mineaki KitamuraDepartment of Nephrology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.
Takahiro TakazonoDepartment of Respiratory Medicine, Nagasaki University Hospital, 1-7-1 Sakamoto, Nagasaki, 852-8501, Japan. takahiro-takazono@nagasaki-u.ac.jp.ORCID http://orcid.org/0000-0002-0696-5386
Naoki HosogayaDepartment of Respiratory Medicine, Nagasaki University Hospital, 1-7-1 Sakamoto, Nagasaki, 852-8501, Japan.ORCID https://orcid.org/0000-0002-3229-2277
Shimpei MorimotoClinical Research Center, Nagasaki University Hospital, Nagasaki, Japan.
Masahiro KinoshitaMedical Affairs Department, Shionogi & Co., Ltd., Osaka, Japan.
Eriko HamadaProduct Safety and Pharmacovigilance, Shionogi Inc., Florham Park, NJ, USA.
Ryosuke ShimizuClinical Pharmacology and Pharmacokinetics, Shionogi & Co., Ltd., Osaka, Japan.ORCID https://orcid.org/0000-0001-9666-8678
Shogo MiyazawaData Science Department, Shionogi & Co., Ltd., Osaka, Japan.
Shintaro TanakaMedical Affairs Department, Shionogi & Co., Ltd., Osaka, Japan.
Tomoya NishinoDepartment of Nephrology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.
Hiroshi MukaeDepartment of Respiratory Medicine, Nagasaki University Hospital, 1-7-1 Sakamoto, Nagasaki, 852-8501, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPatients on hemodialysis (HD) are vulnerable to COVID-19 and often excluded from pivotal antiviral trials. Ensitrelvir, an oral SARS-CoV-2 3C-like protease inhibitor approved in Japan, remains unevaluated in patients undergoing HD. This study assesses the pharmacokinetics, antiviral activity, safety, and clinical effectiveness of ensitrelvir in participants with mild COVID-19 undergoing HD.

methodsIn this prospective, single-arm, open-label study (December 2024-April 2025), participants with mild COVID-19 undergoing HD received ensitrelvir 375 mg on Day 1, followed by 125 mg once daily on Days 2-5. On Visit 2 (Day 3), plasma ensitrelvir concentrations were measured at three time points prior to ensitrelvir administration-before, during, and after dialysis. On Visit 3 (Day 5), blood samples were collected after dialysis and prior to ensitrelvir administration. Clinical outcomes, body temperature, SARS-CoV-2 viral load, and viral titers were monitored through Day 8. The primary endpoint was plasma concentration of ensitrelvir relative to dialysis; secondary endpoints included clinical outcomes, body temperature, and changes in viral load.

resultsEight participants were evaluated: mean age, 68.1 years; mean body weight, 58.0 kg; and mean body mass index, 24.1 kg/m

conclusionNo dose adjustment was required regardless of HD. In participants with mild COVID-19 undergoing HD, plasma ensitrelvir concentrations were similar to those previously reported in healthy individuals. Ensitrelvir showed favorable antiviral and clinical responses, supporting its safe use without dose adjustments.

trial registrationJapan Registry of Clinical Trials ID: jRCTs071240069.

Indexed as

Antiviral therapyCOVID-19EnsitrelvirHemodialysisJapanPharmacokineticsRenal impairmentSARS-CoV-2

Identifiers

PMID41920295
PMCPMC13129023

What Socratic holds

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LicenceCC BY-NC
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.